The Health Canada approval is for the use of Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone in patients who have had 1 to 3 prior lines of therapy.
Full details of the Canadian Kyprolis approval can be found in the drug's "product monograph", the Canadian equivalent of the prescribing information documents which, in the U.S., is the FDA-cleared summary of the approved use of a drug and the clinical evidence related to its use.
We've attached a copy of the Kyprolis product monograph with this posting. It states:
Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone is indicated for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy.
The clinical effectiveness of Kyprolis when combined with lenalidomide and dexamethasone (KRd) has not been established in patients with renal impairment (creatinine clearance [CrCL] < 50 mL/min) or in patients who progressed during prior bortezomib therapy ...
Geriatrics (≥ 65 years of age):
No overall differences in effectiveness of Kyprolis in combination with lenalidomide and dexamethasone were observed between younger (< 65 years of age) and older (≥ 65 years of age) patients. Overall, the patient incidence of certain adverse events (including cardiac failure) in clinical trials was higher for patients who were ≥ 65 years of age compared to patients who were < 65 years of age.
The Canadian approval of Kyprolis is based primarily on data from the ASPIRE clinical trial, which compared Kyprolis, Revlimid, and dexamethasone treatment with Revlimid and dexamethasone alone.
Data from the ASPIRE trial were also the basis for the European approval of Kyprolis.
The Canadian product monograph for Kyprolis does include, however, efficacy and safety data from other clinical trials.
Kyprolis Product Monograph Canada.pdf- (421.74 KiB) Downloaded 35 times
